An Open-label, Non-controlled Study of KHK4827 in Subjects With Psoriasis

A Long-Term Study of KHK4827 in Subjects With Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

This study is an open-label, non-controlled study to evaluate the efficacy and safety of KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma. Pharmacokinetics of KHK4827 will also be assessed.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: KHK4827

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan, 100-8185
      • For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has signed voluntarily the written informed consent form to participate in this study.
• Subject has been diagnosed as pustular psoriasis or psoriatic erythroderma.
• Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.

Exclusion Criteria:

• Subject with psoriatic erythroderma has involved Body surface area (BSA) of lesion < 80% at baseline.
• Subject diagnosed with guttate psoriasis, medication-induced or medication-exacerbated psoriasis.
• Evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of KHK4827 on psoriasis.
• Subject has any active Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher infection
• Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
• Subject has used Ultra Violet B (UVB) therapy within 14 days of the first dose or Ultra Violet A (UVA) (with or without psoralen) within 28 days of the first dose.
• Subject has used etanercept, adalimumab, infliximab or ustekinumab within 1 week, 2 weeks, 8 weeks or 12 weeks of the first dose, respectively.
• Subject has stopped ustekinumab or other anti-Interleukin (IL)-23 biologics therapy due to lack of efficacy
• Subject has used live vaccine within 3 months of the first dose
• Subject has previously used an anti-IL-17 biologic therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: KHK4827	Drug: KHK4827; 140 mg (dosage may be increased to 210 mg in case of insufficient efficacy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression (CGI)	CGI is a 4-point scale that requires the investigators/subinvestigators to assess how much the subject's illness has improved or worsened relative to a baseline state. Scores on the scale are rated as: 1, remission; 2, improved; 3, no change; 4, worsened	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)		52 weeks
American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)		52 weeks
Pustular symptom score (only in subjects with pustular psoriasis)		52 weeks
Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 (only in subjects with psoriatic erythroderma)		52 weeks
sPGA of "clear (0)" at Week 12 (only in subjects with psoriatic erythroderma)		52 weeks
Body surface area involvement (BSA) of lesion at Week 12 (only in subjects with psoriatic erythroderma)		52 weeks
Incidence and types of adverse events and adverse reactions		52 weeks
Laboratory values and vital signs		52 weeks
Profiles of pharmacokinetics	Concentration of KHK4827 in serum	52 weeks
Development of anti-KHK4827 antibody		52 weeks

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: January 27, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (ESTIMATE): February 4, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 16, 2015
• Last Update Submitted That Met QC Criteria: February 12, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Brodalumab
• Other Study ID Numbers: 4827-004